Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms an... | NCT04854486

Studies
Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients

NCT04854486

Sponsor

Larkin Community Hospital

Status

Withdrawn

Last Update Posted

Oct 16, 2023Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Covid19

Interventions

GSE and Xylitol
Control Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study Period Ended / Not Completed

Expanded Access Info

Start Date

Dec 16, 2021Actual

Primary Completion Date

Mar 30, 2022Actual

Completion Date

Nov 16, 2022Actual

First Submitted Date

Apr 17, 2021

First Submission Date that Met QC Criteria

Apr 17, 2021

First Posted Date

Apr 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2023

Last Update Posted Date

Oct 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental	Xylitol + GSE	Other: GSE and Xylitol
Control placebo	Placebo Comparator	Saline	Drug: Control Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSE and Xylitol	Other	Participants are given the experimental treatment to be used for 7 days.	Treatment Group

Measure	Description	Time Frame
Change of time to negativisation via PCR	There will be a change in the time to negativisation via PCR as compared to the average 14-day time to negative result.	Baseline and 7 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Adults of ages 18 to 90 years of both sexes
With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
Signed informed consent
1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
2- Moderate symptoms: Respiratory symptoms such as cough, mild shortness of breath with mild oxygen desaturation(room air SpO2 <92% and >88% or <88% corrected to >92% with 2lt of oxygen)

Exclusion Criteria

Patients with Severe symptoms: Hypoxia (SpO2 <88% not corrected by 2 lt nc oxygen) plus severe shortness of breath (excluded)
Patient with very low viral load (threshold cycle [Ct] > 25 per PCR).
Known hypersensitivity to one of the constituents, particularly to xylitol or GSE
Under 18 years of age
Women of childbearing age who are pregnant, breastfeeding mothers, and intend to become pregnant during the study period; unwilling/unable to take a pregnancy test.
Unable to provide informed consent or decline to consent or unwillingness to adhere to the Standard of Care protocol.
Patients with severe symptoms -Hypoxia (SpO2 <88% not corrected by 2 liter non- concentrated oxygen) plus severe shortness of breath
History of immunodeficiency or are currently receiving immunosuppressive therapy.
Have had a planned surgical procedure within the past 12 weeks.
Already part of this trial, recruited at a different hospital.
Patient unable to perform oro-nasopharyngeal decolonization
Patients with acute exacerbation of severe comorbidities like heart disorders Chronic Obstructive Pulmonary Disease (COPD), Heart Failure New York Heart Association (NYHA) Class 3 and 4 and/or diseases with severe oxygenation problems
Patients on Remdesivir and/or other clinical trials.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Larkin Community Hospital Palm Springs Campus		Miami	Florida	33012	United States
Larkin Community Hospital

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates